A RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED, PHASE I/II, DOSE-RANGING STUDY

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。流感是一种由几种相关病毒引起的常见感染。在美国，它每年造成2万到4万人死亡。当一种新的流感病毒感染人类时，这种感染可以迅速传播到世界各地。这种全球性的传播被称为大流行。在过去的100年里发生了几次大流行。这些大流行造成大量人感染和死亡。1918年，近4000万人死于流感大流行。许多死亡发生在年长者和幼童中。一些新的人类流感病毒来自禽流感病毒。最近，一些禽流感病毒已经感染了亚洲的人。其中一种流感病毒被称为A/H5N1。人们担心这种新病毒可能导致大流行。疫苗可以预防感染和疾病。疫苗的作用是使身体产生一种叫做抗体的蛋白质来对抗感染。有时需要一剂以上的疫苗，这样身体才能产生足够的抗体来对抗感染。已经研制出一些预防流感病毒感染的疫苗。流感疫苗可以预防流感及其引起的健康问题。这些疫苗是由被杀死的流感病毒的部分制成的。这些疫苗被“注射”在手臂上。由美国国家过敏和传染病研究所（NIAID）赞助的这项研究的目的是测试一种灭活的流感疫苗，以预防禽流感病毒a /H5N1。这种疫苗被认为是研究性的（或实验性的）。它从未在人类身上进行过测试。有可能存在我们现在无法预见的风险。这种疫苗的制作方法与目前每年流感季节前给人们接种的“常规”流感疫苗相同。这项研究的目的是找出这种疫苗需要多大的强度才能产生保护水平的“禽流感”抗体，这将有助于我们决定未来如果需要使用的正确剂量。这项研究还将研究人体对不同强度的新型甲型H5N1流感疫苗的反应。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Influenza (the flu) is a common infection caused by several related viruses. It is responsible for 20,000-40,000 deaths each year in the United States. When a new strain of flu infects people, the infection can spread around the world quickly. This worldwide spread is called a pandemic. Several pandemics have occurred in the last 100 years. These pandemics caused infection and death in a high number of people. In 1918, nearly 40 million people died in a flu pandemic. Many deaths occur among the very old and the very young. Some of the new human flu viruses come from bird flu viruses. Recently, some strains of bird flu viruses have infected people in Asia. One of these flu strains is called A/H5N1. There is concern this new strain could cause a pandemic. Vaccines can prevent infection and disease. Vaccines work by causing the body to make proteins called antibodies that fight infection. Sometimes more than 1 dose of vaccine is needed so that the body will make enough antibodies to fight infection. Some vaccines have been developed to prevent infection with flu viruses. Flu vaccines protect against flu and the health problems it causes. These vaccines are made from parts of killed flu virus. These vaccines are given as a "shot" in the arm. The purpose of this research study, which is sponsored by the National Institutes of Allergy and Infectious Diseases (NIAID) is to test a killed flu vaccine for the prevention of the bird flu virus, A/H5N1. This vaccine is considered investigational (or experimental). It has never been tested in humans. There is a possibility there are risks that we cannot foresee right now. This vaccine was made the same way as "regular" flu vaccine that is currently given to people every year before flu season. The purpose of this study is to find out what strength of this vaccine is needed to produce protective levels of "bird flu" antibodies, which will help us decide the right dose for use in the future if it is needed. The study will also look at how the body reacts to different strengths of the new A/H5N1 flu vaccine.